The isCGM Use and Hypoglycemic Episodes and Fear of Hypoglycemia in Newly Diagnosed Type 1 Diabetes

NCT ID: NCT06414824

Last Updated: 2024-10-02

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-01
• Study Completion Date: 2024-05-31

Brief Summary

The aim of this trial is to investigate the impact of FreeStyle Libre use compared to SMBG on hypoglycemia episodes and fear of hypoglycemia in adults aged 18-35 with newly diagnosed type 1 diabetes.

This trial is conducted in university centers in Poland (Bialystok, Krakow, Poznan, Zabrze).

Conditions

Diabetes Mellitus, Type 1

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

FreeStyle Libre

FreeStyle Libre for 4 weeks.

All subjects will wear a masked sensor (FreeStyle Libre Pro) for 14 days prior to randomisation.

Group Type: EXPERIMENTAL

Intermittently Scanned Continuous Glucose Monitoring

Intervention Type: DEVICE

FreeStyle Libre, 4 weeks

SMBG

Subjects randomised to the control group will monitor their blood glucose with standard blood glucose meters.

A 14-day FreeStyle Libre Pro is included for these subjects from day 14 to day 28 to collect glycaemic data for comparison to the intervention group of the study.

All subjects will wear a masked sensor (FreeStyle Libre Pro) for 14 days prior to randomisation.

Group Type: ACTIVE_COMPARATOR

Standard Blood Glucose Monitoring

Intervention Type: DEVICE

Standard blood glucose monitoring with glucose meters

Interventions

Intermittently Scanned Continuous Glucose Monitoring

FreeStyle Libre, 4 weeks

Intervention Type: DEVICE

Standard Blood Glucose Monitoring

Standard blood glucose monitoring with glucose meters

Intervention Type: DEVICE

Other Intervention Names

FreeStyle Libre

Eligibility Criteria

Inclusion Criteria

• Newly diagnosed type 1 diabetes (diagnosed based on the WHO criteria) no later than 6 months after the diagnosis.
• Insulin therapy: multiple daily injections,
• In the investigator's opinion, the participant must be technically capable of using the FreeStyle Libre system

Exclusion Criteria

• Current or past use of any continuous glucose monitoring system.
• Pump therapy.
• Known allergy to medical adhesives.
• Oral steroid therapy.
• Pregnancy or planning pregnancy within the study duration.
• Breast feeding.
• Dialysis treatment.
• Having a pacemaker.
• Unstable coronary heart disease.
• Cystic fibrosis.
• Cancer.
• Psychiatric disorders.
• Severe end-organ damage (kidney, liver, etc) or any uncontrolled disorder.
• Hospitalization for any reason other than the newly diagnosed type 1 diabetes 6 months prior to inclusion.
• Participating in another clinical trial that could affect glucose measurements or glucose management.
• In the investigator's opinion, if the participant is considered unsuitable for inclusion in the study for any other reason.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Diabetes Poland

UNKNOWN

Sponsor Role: collaborator

Jagiellonian University

OTHER

Sponsor Role: lead

Responsible Party

Jerzy Hohendorff

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of Endocrinology, Diabetology and Internal Medicine, Medical University of Bialystok

Bialystok, , Poland

Department of Metabolic Diseases, Jagiellonian University Medical College

Krakow, , Poland

Department of Internal Medicine and Diabetology, Poznan University of Medical Sciences

Poznan, , Poland

Department of Internal Medicine, Diabetology, and Cardiometabolic Disorders, Medical University of Silesia in Katowice

Zabrze, , Poland

Countries

Poland

Other Identifiers

PENELOPE

Identifier Type: -

Identifier Source: org_study_id